Documenting and archiving the Safe Passage Study in NICHD Data and Specimen Hub (DASH)

项目摘要 安全通道研究是第一项前瞻性、观察性、大规模队列研究， 产前接触酒精、烟草和药物对婴儿猝死综合症风险的影响， 胎儿酒精谱系障碍（FASD）。参与者从开普敦的两个地点招募， 南非，以及美国北方平原的五个地点，包括两个美洲印第安人保留地 在2007年到2015年间。这项研究总共招募了10,088名妇女，11,892名孕妇和12,029名胎儿， 随访至分娩后1年。在产前收集了大量的纵向数据， 分娩/新生儿和产后阶段。因此，安全通道研究是一个重要的资源， 对产前暴露、儿童生理和神经发育感兴趣的研究人员， SIDS、死产和FASD的病理学评估。安全通道研究是在NIH之前启动的 数据共享任务，因此没有资金用于编制和存档去身份数据集。到 为利便使用这项宝贵的资源，我们建议公开《安全通道研究》 NICHD Data and Specimen Hub（DASH）数据库我们将存档和记录现有的数据集， 安全通道研究，NICHD与NIAAA和NIDCD一起沿着。更具体地说，我们将1。 准备并提交PASS自我报告和病历摘要数据，如孕产妇和婴儿 特征、心理社会和饮食信息以及暴露评估;以及2.） 准备并提交PASS生理学和病理学数据，如自主神经，呼吸和大脑功能， 胎儿和婴儿、尸检和胎盘评价的病理学评估以及神经学评估 传送到DASH入口我们将执行数据去识别，创建变量字典，准备 使用数据准备工具收集数据集和注释文件，并将安全通道研究提交给NICHD DASH。在该补助金的支持下制作的去识别数据集将不受限制地提供给 研究人员除了在部落土地上收集的数据外，由于在谈判中达成的共享限制， 研究的开始。共享的数据集将使科学界能够进行二次分析， 产前暴露与儿童发育之间的联系。

PROJECT ABSTRACT The Safe Passage Study is the first prospective, observational, large-scale cohort study to investigate the effect of prenatal exposure to alcohol, tobacco and drugs on the risk for Sudden Infant Death Syndrome (SIDS), stillbirth, and Fetal Alcohol Spectrum Disorders (FASD). Participants were recruited from two sites in Cape Town, South Africa, and five sites in the Northern Plains, United States, including two American Indian Reservations between 2007 and 2015. In total, the study enrolled 10,088 women, 11,892 pregnancies, and 12,029 fetuses, followed to 1-year post-delivery. Extensive longitudinal data have been collected during prenatal, delivery/newborn, and postnatal stages. As such, the Safe Passage Study is an important resource for researchers interested in prenatal exposures, child physiological and neurological development, and pathological assessments of SIDS, stillbirth, and FASD. The Safe Passage Study was initiated prior to the NIH data sharing mandate, thus funds were not available for preparation and archiving of a de-identified dataset. To facilitate the use of this valuable resource, we propose to make publicly available the Safe Passage Study datasets via NICHD Data and Specimen Hub (DASH). We will archive and document the existing datasets of Safe Passage Study, which NICHD sponsored along with NIAAA and NIDCD. More specifically, we will 1.) prepare and submit PASS self-reported and medical chart abstraction data, such as maternal and infant characteristics, psychosocial and dietary information, and exposure assessments, to the DASH portal; and 2.) prepare and submit PASS physiology and pathology data, such as autonomic, respiratory, and brain function in the fetus and infant, pathology assessments from autopsy and placental evaluation, and neurologic assessments of the infant to the DASH portal. We will perform data de-identification, create a variable dictionary, prepare datasets and annotation files using the Data Preparation Tool, and submit the Safe Passage Study to NICHD DASH. De-identified data sets produced with support from this grant will be available without restriction to researchers with the exception of data collected on tribal lands, due to sharing restrictions negotiated at the onset of the study. The shared datasets will enable secondary analysis by the scientific community interested in the link between prenatal exposures and child development.